15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
GAUNTLET STAIR CLIMBER
FDA 510(k)
FDA Class 2
·Physical Medicine
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110843·TIP GUARDS VENTED ASSORTED PACK OF 100
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450267448·
STAT PROFILE PHOX PLUS L ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EV1000 Clinical Platform NI, EV1000 Clinical Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH·Product code LWS·November 28, 2015
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code LWS·October 23, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·January 11, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 1, 2010
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDS·July 3, 2014
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·May 18, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·April 18, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·May 5, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·April 26, 2011
B125P Patient Monitor (with E-module slot option), REF 6160000-002
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022